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What You Need to Know About Bioidentical Hormones

When Dallas-based fitness instructor Kimberly Rayburn’s hot flashes started, around age 48, she sought out a physician who would prescribe her bioidentical hormones almost immediately. “I didn’t do well in menopause. Brain fog, fatigue, you don’t sleep a lot … it’s like the worst PMS but it never goes away,” she says.

Today, at 60, she’s taking a compounded mix of hormones and feels great. “I would never ever want to live without my hormones,” she says.

Experiences like Rayburn’s (and The Fine Line founder Sue Cowie’s) are the main reason more women, faced with the many life-altering symptoms of menopause, are seeking out a therapy referred to as “bioidentical hormone therapy” or BHT, which they perceive as more natural and safer than the hormone therapy provided by conventional medicine.

“The buzzword is bioidentical,” says Terese Harris, MD, a Newport Beach-based gynecologist who takes an integrative/functional approach to medicine and says most women who come to her have heard about the therapy from their friends and ask specifically for bioidentical hormones.

However, you’d be hard-pressed to find a more controversial and misunderstood topic in women’s health. Top gynecologists and experts say the therapy has not been shown to be safer or more effective than conventional hormone therapy and could involve serious risks, since many of the hormones have not been studied in the combinations prescribed and are not FDA approved.

This is what you need to know about both sides of the debate, whether you’re struggling with symptoms or want to be prepared for when the time comes.

The Suzanne Somers Effect

For a long time, doctors routinely prescribed hormone replacement therapy (HRT) to most women struggling with symptoms of menopause.

Then, in 2002, researchers working on the massive Women’s Health Initiative (WHI) study stopped administering HRT when they found it led to higher rates of stroke, breast cancer, heart attack, and blood clots. As a result, the FDA required manufacturers to add a “black box” warning to HRT prescriptions, explaining the risks. Use of HRT plummeted.

Since then, however, the results of the study have been further evaluated alongside additional research, explains Lauren Streicher, MD, a professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine and the medical director of the Center for Sexual Health and the Center for Menopause. HRT is now called HT, since hormones are used specifically for symptom relief, not to replace hormones in the amounts women’s bodies used to make. There are now many different drugs available in addition to the ones used in the WHI, and the therapy is often administered in the short term at lower doses, especially in younger women. “If you do it right and in the right person, it’s really safe,” Dr. Streicher says.

At the same time as tracked, government-approved therapies have declined, the use of compounded bioidentical hormone therapy appears to have significantly escalated.

But confusion over hormone therapy is still the rule, so in the midst of all of this, women went looking for other options.

“At the same time as tracked, government-approved therapies have declined, the use of compounded bioidentical hormone therapy appears to have significantly escalated,” says JoAnn V. Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia Health System and the executive director of the North American Menopause Society (NAMS). Though accurate numbers are hard to find, one recent survey found between 28 percent and 68 percent of women using hormones for menopause symptoms take compounded bioidentical hormones.

And many of them are doing so thanks to Suzanne Somers, whose 2007 book and subsequent titles praised bioidenticals as the medical establishment-suppressed secret to being “ageless.” In 2009, Somers told an audience of approximately 6.2 million viewers on Oprah that the “natural” hormones saved her life, prompting a surge of interest.

Integrative medicine stars like Christiane Northrup, MD, saw Somers’ quest as having the potential to help millions of women; other doctors saw it as dangerous.

“These bioidentical compounding people have done an extraordinary marketing job at making people believe they’re better and safer than what you’re getting commercially,” Dr. Streicher says. “These are women who desperately need help. I don’t blame women for going to Suzanne Somers, because their own doctors weren’t helping them.”

What Are Bioidentical Hormones and Can They Help?

“The term bioidentical hormones refers to hormones that are biochemically similar to the hormones made endogenously within the human body,” Dr. Pinkerton explains.
Women in the WHI study were taking Premarin, an estrogen made from the urine of pregnant horses, and Prempro, a drug that combine Premarin with synthetic progesterone. Unlike Premarin, bioidentical estrogens — like Estrace and Estraderm — are made from plant compounds extracted from yams and soy and are identical in molecular structure to human estrogen. Hence, their reputation for being more “natural.”

That fact is intuitively satisfying, but Dr. Pinkerton points out that while they’re touted as natural, bioidentical hormones are just as much a drug as any other. “Regardless of what precursor they come from, often soy or yam, they need to be chemically changed to allow them to either be absorbed by the body or become active,” she says.

And Dr. Streicher says the “naturalness is irrelevant. We’re a lot closer to horses than we are to plants. I don’t prescribe them because they’re natural. I prescribe them because they’re handled by the body better.”

The Compounding Controversy

Yes, you read that right. Here’s one of the biggest misconceptions: conventional physicians actually prescribe FDA-approved bioidentical hormones all the time. And there is some limited evidence they may be safer. One study found women who took a bioidentical form of progesterone combined with estrogen (both groups took bioidentical estrogen) had lower risk of breast cancer compared to women administered a non-bioidentical form of progesterone.

What doctors take issue with are the bioidentical hormones mixed in compounding pharmacies, which are usually what is being referred to when the topic is discussed.

Integrative physicians like Dr. Harris, for example, use lab results from saliva, urine, and blood combined with a patient’s symptoms to prescribe a specific mix of hormones (generally some combination of estrogen, progesterone, and testosterone).

“I prefer compounded medications because I practice medicine specific to the person,” she says, noting that it also allows her to prescribe at even lower doses than are available via traditional pharmaceuticals.

One investigation in 2013 found that many compounded drugs don’t contain the levels they are labeled with.

Dr. Streicher and other physicians counter that all of the lab testing is unnecessary and there’s no evidence to show correlating prescriptions to hormone levels in saliva or blood is effective. “It’s like saying, ‘I’m going to mix up a birth control pill for you,’” she says. “Would you have your birth control mixed up? No, you just see which works for your body by looking at the symptoms you have.”

At the pharmacy, the hormones being mixed together are generally the same bioidentical drugs being prescribed by conventional physicians. However, since they’re being mixed in varying doses and combinations, there are no clinical trials verifying their safety, so the FDA will not approve them. One investigation in 2013 found that many compounded drugs don’t contain the levels they are labeled with. (Dr. Harris says one key factor is making sure women are going to compounding pharmacies accredited by PCAB, a board that oversees the operations.)

And over- or underdosing is a serious concern, Dr. Streicher says, since unlike Dr. Harris, many of the physicians prescribing compounded bioidenticals are not board-certified gynecologists. (A quick search in a bioidentical doctor web directory confirms this. Most are general practitioners, and many are not MDs.)

A possible risk? HT with estrogen raises the risk of uterine cancer if it’s not balanced correctly with progesterone, and physicians fear women will get combinations that are not properly balanced via prescribers who are not experts in the field or improperly mixed compounded drugs.

The Bottom Line

What we really know is this: Health practitioners are putting out two conflicting messages that women will have to reconcile when deciding what’s right for them.

Dr. Harris says compounded bioidenticals are the best, safest way to find relief from menopause symptoms. Meanwhile, Dr. Pinkerton advises: “Based on concerns raised by NAMS and other national organizations, it is safer for women to have a ‘buyer beware” approach and ask why compounded bioidentical hormones are being recommended over tested, effective, monitored, government-approved therapies.”

When I ask Rayburn if it concerns her that her regimen has never been studied in a clinical trial, she doesn’t miss a beat. “It doesn’t,” she says. “I feel so good, and I’m 60 years old and I’ve had wonderful experiences, and maybe I’m a guinea pig, and it doesn’t bother me a bit.”

Just be sure you’ve got all of the facts before deciding to make yourself said guinea pig. In the end, only you (and your doctor!) can decide.

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